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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02006953
Other study ID # HUM00046483
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date August 2011
Est. completion date November 7, 2018

Study information

Verified date January 2019
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the best way to feed children after they have a gastrostomy tube placed. The study compares bolus feeding to continuous feeding.


Description:

This study will consist of a prospective, randomized comparison of bolus versus continuous enteral feeding protocols in pediatric patients with gastrostomy tubes


Recruitment information / eligibility

Status Terminated
Enrollment 97
Est. completion date November 7, 2018
Est. primary completion date July 18, 2018
Accepts healthy volunteers No
Gender All
Age group N/A to 17 Years
Eligibility Inclusion Criteria:

- Less than 18 years of age

- Admitted for gastrostomy tube placement, with or without Nissen Fundoplication

Exclusion Criteria:

- Immunocompromised patients

- Short Bowel Syndrome (SBS)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Bolus feeding schedule following gastrostomy tube placement

Continuous chimney feeds following gastrostomy tube placement


Locations

Country Name City State
United States University of Michigan, CS Mott Children's Hospital Ann Arbor Michigan
United States Mercy Children's Hospital Toledo Ohio

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of gastrostomy tube leakage Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks. 8 weeks
Secondary Emesis Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks. 8 weeks
Secondary Retching Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks. 8 weeks
Secondary Venting beyond recommendations Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks. 8 weeks
Secondary Feeding changes Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks. 8 weeks
Secondary Unscheduled clinic/ER visits/calls Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks. 8 weeks
Secondary G-tube infection Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks. 8 weeks
Secondary Weight Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks. 8 weeks
Secondary Time to goal feeds Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks. 8 weeks
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